OBJECTIVES

: To evaluate the costs and health outcomes of using Pioglitazone in combination with insulin compared to insulin mono-therapy in treating patients with Type 2 Diabetes Mellitus (T2DM) in Iran.

METHODS

: A model-based economic evaluation through CORE diabetes model was performed. A systematic review and meta-analysis was conducted in order to evaluate the clinical effectiveness of the comparators. Relative randomized controlled trials, based on the inclusion criteria, were included. Treatment effect data including change in glycozilated hemoglobin (HbA1c), insulin daily dose, serum lipids, and Body Mass Index BMI) were taken from included trials. Costs were calculated from payer perspective. Quality-adjusted life years (QALYs) and life years gained (LY) were measured to evaluate the effectiveness of alternatives. The price list of pioglitazone and varied forms of insulin were extracted from Iran Food and Drug Administration website. One-way sensitivity analysis was performed for assessing the robustness of the model.

RESULTS

: The 7618 studies were found in the first phase of searching through databases. After eliminating duplicate studies and studies incompatible with the inclusion and exclusion criteria of our study, 12 study were selected. In meta-analysis, the mean reduction in HbA1c, for combination therapy of insulin with pioglitazone, was 0.64%, which was statistically significant (95% CI: -0.86, -0.41, p<0.00001). The combination therapy of Pioglitazone (15 and 30 mg dosage forms) plus insulin, was associated with an incremental cost-effectiveness ratio of 408.6 $ USD per QALY versus insulin mono-therapy.

CONCLUSIONS

: Our results suggest that the addition of pioglitazone to insulin regimen would be highly cost-effective treatment approach in Iranian T2DM patients.